Regulatory & Quality
Building confidence in every submission. We establish quality systems, define regulatory strategy and compile the objective evidence needed for market approval — and for keeping products compliant afterwards.
Organisations we support.
- Companies determining whether their software qualifies as a medical device, and at what class.
- Teams establishing a quality management system for the first time.
- Manufacturers preparing UK or EU submissions for software-based products.
- Organisations with products on the market that need their post-market obligations to work in practice.
What typically goes wrong.
- Uncertainty over qualification and classification, leading to the wrong regulatory route.
- A quality system written to pass audit but unusable by the engineering team.
- Design controls that exist as documents rather than as how the product is actually developed.
- Risk management treated as a one-off deliverable instead of a live file.
- Technical Documentation assembled late, with gaps that only surface under review.
The work we perform.
Qualification & classification
Determining device status, classification and the applicable regulatory requirements.
Regulatory strategy
Defining the pathway, target markets, evidence requirements and sequencing.
ISO 13485 QMS
Quality systems built to work in practice for software teams, not just on paper.
Design controls
Design and development controls integrated with how your engineers actually work.
ISO 14971 risk management
Hazard identification through to a maintained Risk Management File.
Technical Documentation
Compiling and strengthening the full body of evidence required for submission.
UK MHRA
Registration and UK market access, including UKCA and approved-body engagement.
EU MDR / IVDR
EU submissions and notified-body support, where applicable to your product.
FDA support
Advisory support for US-bound programmes, working with your US regulatory counsel where required.
Post-market compliance
Vigilance, post-market surveillance, software change control and CAPA.
What you might receive.
Scope is agreed per engagement — the outputs below are typical examples.
Regulatory strategy written without engineering input tends to describe a product nobody is building. Our regulatory specialists sit with the engineers, so classification, risk controls and documentation reflect the real architecture — and the evidence exists because the work was done that way.
Preparing for submission?
We'll help you understand what's required, what you already have and what's missing.